Early Versus Delayed Oxytocin Infusion Following Amniotomy in Nulliparous Women
Primary Purpose
Delivery Delayed, Mode of Delivery, Post Partum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
duration of initiation of oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Delivery Delayed focused on measuring primigravida, amniotomy,, immediate oxytocin, delayed oxytocin
Eligibility Criteria
Inclusion Criteria:
- gestational age between 36+0 to 41+6 weeks
- singleton pregnancies in cephalic presentation
- estimated fetal weight between 2.5 - 4.0 kg
- cervical dilatation of 4 cm with intact membranes
- normal fetal heart rate trace before artificial rupture of membranes
Exclusion Criteria:
- Women with significant medical (eg. heart disease, pre-eclampsia, diabetes with high dose insulin, retroviral disease)
- fetal abnormality (eg. fetal growth restriction or small for gestational age < 2.5 kg, suspected macrosomia > 4.0 kg, fetal anomaly)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early oxytocin Infusion
Late oxytocin infusion
Arm Description
labour augmentation with oxytocin was started early following amniotomy.
oxytocin augmentation was delayed at two hours after amniotomny and this practice is currently being used as standard protocol in this hospital to manage women in labour.
Outcomes
Primary Outcome Measures
Achieving vaginal delivery
number of normal vaginal delivery
Neonatal outcome
Apgar score
Secondary Outcome Measures
Full Information
NCT ID
NCT04200599
First Posted
December 11, 2019
Last Updated
December 12, 2019
Sponsor
National University of Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT04200599
Brief Title
Early Versus Delayed Oxytocin Infusion Following Amniotomy in Nulliparous Women
Official Title
Amniotomy and Early Oxytocin Infusion Versus Amniotomy and Delayed Oxytocin Infusion in Nulliparous Women: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
January 30, 2016 (Actual)
Study Completion Date
March 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In UKM Medical Centre (UKMMC), delayed oxytocin augmentation at two hours following amniotomy is the routine obstetric practice in spontaneous or induced labour with intact membranes. This practice may potentially cause prolonged labour, extended labour room occupancy and increased maternal exhaustion while no additional benefit can be gained. On the other hand, recommendation for early oxytocin augmentation poses a dilemma as the effectiveness and safety of this practice are still in doubt.
Given this background, the aim of this study was to compare the effect of early versus delay oxytocin infusion in achieving successful vaginal delivery among the low-risk nulliparous women in UKMMC. Besides, this study also compares the adverse maternal and neonatal outcomes between the two practices.
Detailed Description
This was a randomised controlled trial undertaken in the labour room of UKMMC for a period of eighteen months from August 2014 until February 2016. Eligible women who were admitted in spontaneous labour or for induction of labour were recruited. For women who underwent induction of labour, an interval of at least six hours following vaginal prostaglandin before recruitment was mandatory to avoid overlapping effect of prostaglandin and oxytocin. Upon enrolment, each patient was given a study explanation and written consent was obtained.
The randomisation sequence, either to the early oxytocin group or the delayed oxytocin group, was generated using the computer randomisation program in block of two. Allocation to either arm of treatment was determined by the sequential opening of sealed numbered envelopes.
In the first arm of early oxytocin group, labour augmentation with oxytocin was started early following artificial ruptured of membrane(ARM). In the second arm of delayed oxytocin group, oxytocin augmentation was delayed at two hours after ARM and this practice is currently being used as standard protocol in this hospital to manage women in labour. In both arms,the infusion rate was doubled every 30 minutes to a maximum of 48 mL/h or until four to five moderate contractions per 10 minutes were achieved at which point the infusion rate was maintained. Continuous fetal heart rate monitoring was maintained throughout the intrapartum period. Vaginal examination was performed at four hours after ARM as well as when clinically indicated ie. abnormal cardiotocography (CTG) and maternal desire to bear down. In the presence of abnormal CTG, either fetal blood sampling or expedited delivery was undertaken as per decided by the obstetrician in charge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delivery Delayed, Mode of Delivery, Post Partum Hemorrhage, Uterine Hyperstimulation
Keywords
primigravida, amniotomy,, immediate oxytocin, delayed oxytocin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early oxytocin Infusion
Arm Type
Experimental
Arm Description
labour augmentation with oxytocin was started early following amniotomy.
Arm Title
Late oxytocin infusion
Arm Type
Active Comparator
Arm Description
oxytocin augmentation was delayed at two hours after amniotomny and this practice is currently being used as standard protocol in this hospital to manage women in labour.
Intervention Type
Other
Intervention Name(s)
duration of initiation of oxytocin
Intervention Description
mode of delivery
Primary Outcome Measure Information:
Title
Achieving vaginal delivery
Description
number of normal vaginal delivery
Time Frame
through study completion, an average of 18 months
Title
Neonatal outcome
Description
Apgar score
Time Frame
through study completion, an average of 18 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
all primigravida
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
gestational age between 36+0 to 41+6 weeks
singleton pregnancies in cephalic presentation
estimated fetal weight between 2.5 - 4.0 kg
cervical dilatation of 4 cm with intact membranes
normal fetal heart rate trace before artificial rupture of membranes
Exclusion Criteria:
Women with significant medical (eg. heart disease, pre-eclampsia, diabetes with high dose insulin, retroviral disease)
fetal abnormality (eg. fetal growth restriction or small for gestational age < 2.5 kg, suspected macrosomia > 4.0 kg, fetal anomaly)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad azrai abu
Organizational Affiliation
Department of Obstetrics and Gynecology, UKM Medical Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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Early Versus Delayed Oxytocin Infusion Following Amniotomy in Nulliparous Women
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